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Government halts HIV vaccine trial after shot fails to prevent infections

Posted by on Apr. 27, 2013 at 7:41 PM
  • 8 Replies
A U.S. government study of an experimental HIV vaccine has been halted effective immediately, because the vaccine did not prevent HIV infection in some volunteers.

The study, called the "HVTN 505 clinical trial," kicked off in 2009 and had enrolled about 2,500 people in 19 cities. Participants were all men who have sex with men and transgender people who have sex with men. Half received an experimental vaccine developed by the National Institutes of Health, and half received dummy, or placebo, shots.

A scheduled safety review on April 22 found that slightly more volunteers who had received the vaccine later became infected with HIV. Overall, 41 cases of HIV infection occurred in the volunteers who received the experimental vaccine and 30 cases of HIV infection occurred among the recipients who received the dummy injection.

It's not clear why, but the National Institute of Allergy and Infectious Diseases - a branch of the NIH -- noted the increased risk of HIV among vaccine group was not statistically significant when compared to the placebo group, meaning the findings may be due to chance.

The safety review also showed the vaccine failed to reduce the amount of HIV virus in the blood, called the "viral load," in people who had been diagnosed with HIV and were tracked for 20 weeks of follow-up.

The NIH said in a statement Thursday that it is stopping vaccinations, but will continue to study the volunteers' health.

http://m.cbsnews.com/storysynopsis.rbml?&pageType=health&url=http%3A%2F%2Fwww.cbsnews.com%2F8301-204_162-57581454%2Fgovernment-halts-hiv-vaccine-trial-after-volunteers-infected%2F&catid=57581454&nb_splitPage=0
by on Apr. 27, 2013 at 7:41 PM
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Replies (1-8):
SallyMJ
by Ruby Member on Apr. 27, 2013 at 9:49 PM

So did the NIH tell the test subjects to STOP practicing safe sex?? Why 

Until it has been proven,  and even if so - given the seriousness of the illness - I don't think it is wise to tell test subjects to stop using safe sex methods.

I mean, geez - doctors practically shake women who take Accutane, tell them to use two forms of birth control, because of horrible birth defencts. I can't think of too many things more horrible that contracting HIV - even if it is not a death sentence as it was in the 80s and 90s.

kcangel63
by Amanda on Apr. 27, 2013 at 9:54 PM
I don't know. I was wondering that myself. Especially since so many more who got the vaccine ended up with HIV.

Personally, I'd be too afraid of the vaccine giving me HIV.


Quoting SallyMJ:

So did the NIH tell the test subjects to STOP practicing safe sex?? Why 

Until it has been proven,  and even if so - given the seriousness of the illness - I don't think it is wise to tell test subjects to stop using safe sex methods.

I mean, geez - doctors practically shake women who take Accutane, tell them to use two forms of birth control, because of horrible birth defencts. I can't think of too many things more horrible that contracting HIV - even if it is not a death sentence as it was in the 80s and 90s.

gludwig2000
by Gina on Apr. 28, 2013 at 10:45 PM

 Scary situation, all the way around. I feel for the men who thought they were protected and weren't careful, but you know, they should have still practised safe sex, imo. And I don't like any new vaccines, I don't trust them.

kcangel63
by Amanda on Apr. 28, 2013 at 11:40 PM
I agree. I don't understand why someone would put their life on the line like that. First, no vaccine is 100%. Second, they didn't even know IF it worked. Obviously it didn't. That is sad. I wonder if they ended up passing the virus to other partners?

:(


Quoting gludwig2000:

 Scary situation, all the way around. I feel for the men who thought they were protected and weren't careful, but you know, they should have still practised safe sex, imo. And I don't like any new vaccines, I don't trust them.

kailu1835
by Silver Member on Apr. 29, 2013 at 1:57 AM

Well that's got to be a first.  If only they'd called a halt to the other vaccines that fail to work.

marilyn623
by New Member on Apr. 29, 2013 at 2:01 AM
Wtf!
JakeandEmmasMom
by Gold Member on Apr. 29, 2013 at 8:41 AM

 Wow.  That's too bad.

Analeigh2012
by Silver Member on Apr. 29, 2013 at 10:01 AM
It was a clinical trial. Participants would have been warned against all the potential outcomes which would include contracting HIV and therefore the study showed the incident rate between the groups to be statistically insignificant. That means that the incident rate from the drug trial group and the incident rate from the placebo group were so close that the variance is not significant. Because people entering the trial would not be told if they were taking the vaccine or the placebo, they would not have been told to change their habits (ie - stop using protection). NIH uses the highest standards in clinical trials. This is why, even though the incident rates would not warrant a halt in the program, they decided to halt human trials and continue studying the participants health as well as the drug. They are to be commended for stopping the trials. Most likely, the participants made the choice to involve in risky behavior because they "thought" they were protected. Human behavior cannot be controlled in a trial like this - only monitored.

I worked in Research & Development at a pharmaceutical company (before changing careers to human resources) and participated in drug trials from the manufacturer's perspective.
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